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NCT Number: NCT07280507

Comparing Microneedling and Injectable Platelet Rich Fibrin to Hyaluronic Acid In Papilla Reconstruction

This randomized split-mouth clinical trial aims to compare the clinical effectiveness of microneedling combined with injectable platelet-rich fibrin (i-PRF) versus hyaluronic acid (HA) gel injection in the reconstruction of Class I interdental papilla loss. The study hypothesizes that MN + i-PRF will yield greater papillary regeneration, offering a minimally invasive, biologically active alternative to traditional surgical approaches for soft-tissue esthetic rehabilitation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Papilla Reconstruction

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

King AbdulAziz University

Jeddah, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Plaque index <1
  • Gingival index <1
  • Class I papillary loss (Nordland and Tarnow classification)
  • Probing depth ≤4 mm at the test site
  • Inter-proximal bone crest distance ≤7 mm from the contact point.

Exclusion criteria

  • Pregnancy
  • Lactation
  • Uncontrolled systemic diseases (e.g., diabetes)
  • Anticoagulant therapy
  • Recent radiotherapy
  • Orthodontic treatment
  • Midline diastema
  • High frenum attachment
  • Class II/III papillary loss.

Treatment and study plan

Injectable Platelet Rich Fibrin

Biological

Injectable Platelet Rich Fibrin

Hyaluronic Acid (HA)

Other

Filler

Primary outcomes

  1. Papillary height

    Time frame: Baseline, 6 weeks, and 12 weeks.

    from the mucogingival junction to the papilla tip

  2. Papillary width

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Comparative Evaluation of Microneedling With Injectable PRF and Hyaluronic Acid for Papilla Reconstruction: A Randomized Clinical Trial

Acronym: (PRF) (HA)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 12, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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